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OpenTrials
Completed

NCT Number: NCT05634291

Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain

The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

This is a run-in design, feasibility study that uses the enrolled participants as their own control. After consenting to join the study, for the first 30 days, participants will be on their current Standard of Care (SoC). Then, for the next 30 days, the same group of participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment period measures of opioid use and pain, quality of life measures will be administered and measured. Additionally, for qualifying participants, Pre- and Post-treatment functional Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy affects neuroplastic changes in the supraspinal pain network associated with the therapy sessions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults ages 21-80
  • Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily
  • Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.

Exclusion criteria

  • Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
  • Current active alcohol or substance use disorder as evidenced from medical record
  • Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
  • Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
  • fMRI exclusion only: Any factors that would prevent participation in fMRI

Treatment and study plan

Standard of care

Other

Standard of care as prescribed by healthcare provider.

Nottingham AR smartphone app with active intervention

Device

AR software treatment delivered by smartphone app and developed by VRx Medical (VRx) using established principles of illusion therapies (e.g. mirror therapy) for pain management.

Primary outcomes

  1. The Pain, Enjoyment of Life and General Activity scale (PEG)

    Time frame: Change from baseline to day 30

    PEG is a three-Item scale assessing pain intensity and interference. Scale is from 0 (no pain) to 10 (pain as bad as you can imagine).

  2. Milligrams of Morphine Equivalent (MME)

    Time frame: Change from baseline to day 30

    MME is a standard measure of opioid use

Secondary outcomes

  1. Resting State brain imaging data

    Time frame: Change from baseline to day 30

    fMRI compare pre- to post treatment - imaging data to show hyperactivities and enhanced functional connectivity in supraspinal regions associated with the affective aspect of pain perception.

  2. Non-opioid pain medicine usage

    Time frame: Change from baseline to day 30

    Pain medicine usage will be tracked for dose and frequency.

  3. Pain Disability Index (PDI)

    Time frame: Change from baseline to day 30

    PDI is a standard questionnaire designed to help patients measure the degree their daily lives are disrupted by chronic pain.

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: Change from baseline to day 30

    PHQ-9, a Quick Depression Assessment, is a reliable and valid measure of depression. severity

Sponsors and collaborators

Lead sponsor

VRx Medical Inc

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • San Diego Veterans Healthcare System

Registry information

Official study title

Effects of the Nottingham Arthritis App for Arthritis Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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